BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFILE 8 FR. 40CC IAB WITH GLI

    MDR report key: 431537 · Received December 6, 2002

    Report

    Report Number
    2248146-2002-00008
    Event Type
    Injury
    Date Received
    December 6, 2002
    Date of Event
    September 25, 2002
    Report Date
    November 4, 2002
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE IAB WAS INSERTED INTO THE PATIENT IN 2002 IN THE CATH LAB DURING PROCEDURE FOR DIAGNOSTICS. THE PATIENT WAS RETURNED TO CCU. AFTER IABP FOR THREE HOURS, "LEAK IN IABP CATH" SOUNDED FROM THE SYSTEM 98XT AND BLOOD WAS SEEN IN THE GAS LINE. THE LAB WAS REMOVED AND A SECOND IAB WAS INSERTED. EVENT COMPLICATIONS: UNSTABLE, ABDOMINAL PAIN, MOTTLED LEGS, BLINDNESS-RPT'D 11/4, PT'S CURRENT STATUS: UNSTABLE-RPT'D 11/04/02.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILE 8 FR. 40CC IAB WITH GLI * DSP DATASCOPE CORPORATION 0684 00 0320 1194

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening